Main description:

The truth is, few people know the first thing about clinical research. The public reads about a medical research project that announces unbelievable results for a miraculous drug. Some years later, another investigation completely wipes out those initial favorable findings. Hormones Cut Women's Risk of Heart Disease (San Francisco Chronicle, 1994) Hormones Don't Protect Women from Heart Disease, Study Says (Washington Post, 2001) The people are confused because we do not understand the process behind these conflicting results. Our health, and in fact, our very lives are dependent on clinical trials, but we know little about them. This book explains the issues the public needs to be aware of when it comes to clinical research. It uncovers the problems in medical investigations that can not be overcome no matter how much care and diligence medical researchers bring to a research project. The basic premise that drives the writing is that it is impossible for medical researchers to guarantee that they can get all the right answers from a single study. No matter how good the investigators are, no matter how well a study is planned, no matter how carefully the plans are executed and no matter how conscientiously the results are analyzed and interpreted - the answer may still be wrong. The deck is stacked against medical researchers and the public - you - should be skeptical of the results no matter how impressive they seem on the surface.

Contents:

Preface Part One: Medical Research Explained Chapter 1. Medical Research - Searching For Answers
Chapter 2. The Case-Control Method - Looking Backward
Chapter 3. The Cohort Study - Watchful Waiting
Chapter 4. The Clinical Trial - The Gold Standard
Chapter 5. Comparing The Methods - Qualitative Differences Part Two: Understanding The Clinical Trial Chapter 6. The Protocol - The Guiding Light
Chapter 7. The Control Group - Leveling The Playing Field
Chapter 8. Measurements - They're Never Exact
Chapter 9. Bias Control - A Closer Look At Blinding And Randomization
Chapter 10. Utility -Are Clinical Trial Results Useful?
Chapter 11. Research Discrimination - Inadequately Tested Populations
Chapter 12. Seven Deadly Flaws - The Achilles' Heel Of The Clinical Trial Part Three: Tools Of The Trade Chapter 13. Statistics - Was The Finding Significant?
Chapter 14. Analysis Issues - A Lot Of Choices
Chapter 15. The Meta Analysis - An Alternative To Large Trials Part Four: The Real World Chapter 16. Research Results that Clashed - What's The Right Answer?
Chapter 17. Hormone Replacement Therapy - The Silver Bullet That Misfired
Chapter 18. Publishing - Getting The Word Out To Doctors
Chapter 19. Communicating - Sharing The News With The Public
Chapter 20. Product Development - Getting Discoveries To The Market
Chapter 21. Medical Innovation - Regulators, Resources And Results
Chapter 22. Science And Politics - A Troubling Mixture
Chapter 23. Research Misconduct - Irresistible Temptation
Chapter 24. Postmarketing Surveillance - An Imperfect System
Chapter 25. Regulatory Reform - Changes Needed
Chapter 26. Journey's End - A Call For Action Notes/Bibliography
Glossary
Index